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White House Knocks FDA Bill For 'Burdensome' Safety Provisions

Updated May 2, 2007 12:01 a.m. ET

The White House said it has "serious concerns" about certain drug-safety provisions in a bill to reauthorize a law allowing the Food and Drug Administration to charge user fees to pharmaceutical and medical-device firms. One of the provisions in the bill, which is being debated by the Senate, would require the FDA to review the safety profile of new drugs twice after they are first approved. The Bush administration said this "would require significant resources to implement burdensome process changes that will not contribute meaningfully to improving drug safety."